Lawsuit Over Tepezza and Hearing Loss Filed Against Horizon Therapeutics

Infusions of Tepezza caused hearing loss problems that were not disclosed by the drug maker, and could have been avoided if warnings about the importance of audiological monitoring had been provided, according to lawsuit.

A Georgia woman has brought a product liability lawsuit against Horizon Therapeutics, alleging the drug maker has failed to adequately disclose information about the link between Tepezza and hearing loss, which left her with permanent damage after receiving the thyroid eye disease drug.

The complaint (PDF) was filed by Angela Simpson in the U.S. District Court for the Middle District of Georgia on March 21, indicating Horizon knew or should have known Tepezza causes hearing loss and other symptoms, including ringing in the ears or tinnitus, yet failed to provide warnings for users and the medical community, including recommendations that all users should undergo audiological monitoring after the infusions.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment which was just introduced in January 2020, as the first medication approved to treat thyroid eye disease or bulging eyes, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Although Tepezza was originally intended as a niche treatment, with only a limited market, during the second year the drug was on the market in the United States sales doubled to $1.66 billion, and critics have expressed concern that Tepezza was aggressively marketed without adequately disclosing all of the potential risks.

Hundreds of former users are now coming forward to report that they experienced various forms of hearing damage from Tepezza, with many of the problems persisting long after last use of the medication.

Simpson indicates she was diagnosed with thyroid eye disease, or Graves’ disease, in June 2020, at which time she received infusions of Tepezza to treat the condition. She received the infusions through December 2020, and began to experience hearing damage as a result, the lawsuit alleges.

“Plaintiff and Plaintiff’s physicians were given no warning and had no knowledge of the serious risk of permanent hearing loss and/or tinnitus Tepezza posed,” the lawsuit states. “(T)here is no warning or indication that Tepezza can, and in fact does, cause permanent hearing damage. Nor are physicians directed by Defendant to conduct baseline audiology testing before treatment with Tepezza, or monitor hearing acuity during treatment.”

The lawsuit claims that Horizon should have been aware of the link between Tepezza and hearing loss before it was ever submitted to U.S. regulators for review, since the drug impacts the insulin-like growth factor I, which is known to play a central role in hearing and low levels have been shown to correlate with human syndromes associated with hearing loss.

However, the drug maker failed to adequately test Tepezza, ignored pose marketing reports that clearly indicated users were experiencing hearing loss, and provided false and misleading information about the safety risks with Tepezza, according the lawsuit.

Simpson presents claims for failure to warn and design defects, under theories of both negligence and strict liability. As a result of the connection between Tepezza and hearing loss, the lawsuit seeks both compensatory and punitive damages.

March 2023 Tepezza Lawsuit Update

Simpson’s complaint joins nearly a dozen Tepezza lawsuits already pending in the the U.S. District Court for the Northern District of Illinois, where a group of plaintiffs filed a motion to centralize the Tepezza hearing loss claims before one judge in December 2022, to avoid duplicative discovery in different cases, contradictory pretrial rulings and conflicting scheduling orders.

Although the size and scope of the litigation is expected to continue to increase rapidly, Horizon Therapeutics has objected to the proposed consolidation, claiming the cases involve substantially enough different facts and defenses that they would not benefit from coordinated pretrial proceedings. Instead, the drug maker has filed motions to dismiss the lawsuits, arguing that it should be insulated from liability for failing to warn under a theory of federal preemption, arguing that the FDA would have to approve a label update.

Plaintiffs maintain that ultimate responsibility for the safety and warnings provided falls on the drug maker, indicating that if they are going to sell and profit from a medication they need to conduct adequate research and disclose all known or knowable risk information.

Additional lawsuits over Tepezza and hearing loss will continue to be filed throughout 2023, and lawyers provide free consultations and claim evaluations to help individuals determine if financial compensation may be available.